An updated analysis on myocarditis and pericarditis cases reported following mRNA SARS-CoV-2 vaccination in Singapore.

INTRODUCTION: Messenger ribonucleic acid (mRNA) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines have been associated with myocarditis/pericarditis, especially in young males. We evaluated the risk of myocarditis/pericarditis following mRNA vaccines by brand, age, sex and dose number in Singapore. METHODS: Adverse event reports of myocarditis/pericarditis following mRNA vaccines received by the Health Sciences Authority from 30 December 2020 to 25 July 2022 were included, with a data lock on 30 September 2022. Case adjudication was done by an independent panel of cardiologists using the US Centers for Disease Control and Prevention case definition. Reporting rates were compared with expected rates using historical data from 2018 to 2020. RESULTS: Of the 152 adjudicated cases, males comprised 75.0%. The median age was 30 years. Most cases occurred after Dose 2 (49.3%). The median time to onset was 2 days. Reporting rates were highest in males aged 12-17 years for both primary series (11.5 [95% confidence interval [CI] 6.7-18.4] per 100,000 doses, post-Dose 2) and following booster doses (7.1 [95% CI 3.0-13.9] per 100,000 doses). In children aged 5-11 years, myocarditis remained very rare (0.2 per 100,000 doses). The reporting rates for Booster 1 were generally similar or lower than those for Dose 2. CONCLUSIONS: The risk of myocarditis/pericarditis with mRNA vaccines was highest in adolescent males following Dose 2, and this was higher than historically observed background rates. Most cases were clinically mild. The risk of myocarditis should be weighed against the benefits of receiving an mRNA vaccine, keeping in mind that SARS-CoV-2 infections carry substantial risks of myocarditis/pericarditis, as well as the evolving landscape of the disease.

Clinical and neurocognitive outcomes after transcatheter aortic valve implantation (TAVI) with cerebral protection: initial experience with a novel dual-filter device in Southeast Asia.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is increasingly performed in patients with severe aortic stenosis. A novel dual-filter system to reduce cerebral embolism during TAVI recently became available. We aimed to assess the feasibility, safety, and clinical and neurocognitive outcomes of TAVI with cerebral protection in Asian patients. METHODS: 40 consecutive patients undergoing TAVI with cerebral protection were enrolled. All procedures were performed via femoral access using the self-expanding Evolut R/PRO or Portico, or the balloon-expandable SAPIEN 3 bioprostheses. Baseline characteristics, procedural and clinical outcomes were recorded. Cognition was assessed at baseline and 30 days using the abbreviated mental test (AMT). RESULTS: The mean age of the patients (75% male) was 76.4 ± 8.4 years. TAVI was uncomplicated in all patients. The filter device was successfully deployed in 38 (95.0%) patients without safety issues. There was no stroke or death at 30 days, and the survival rate at nine months was 95.0%. There was no overall cognitive change (baseline vs. 30-day AMT: 9.2 ± 1.1 vs. 9.0 ± 1.5, p = 0.12), and only 1 (2.5%) patient developed impaired cognition at 30 days. Patients with a decreased AMT score at 30 days were significantly older than those without (82.1 ± 4.5 vs. 74.4 ± 7.7 years, p = 0.019). All patients with decreased AMT scores were aged ≥ 76 years. CONCLUSION: In this early Asian experience of TAVI under cerebral protection, the filter device was successfully deployed in 95% of patients, with 100% procedural success. There were no filter-related complications and no stroke or mortality at 30 days. Overall cognition was preserved, although increased age was associated with a decline in AMT score.

Pericarditis and myocarditis after COVID-19 mRNA vaccination in a nationwide setting.

INTRODUCTION: Despite reports suggesting an association between COVID-19 mRNA vaccination and pericarditis and myocarditis, detailed nationwide population-based data are sparsely available. We describe the incidence of pericarditis and myocarditis by age categories and sex after COVID-19 mRNA vaccination from a nationwide mass vaccination programme in Singapore. METHODS: The incidence of adjudicated cases of pericarditis and myocarditis following COVID-19 mRNA vaccination that were reported to the vaccine safety committee between January to July 2021 was compared with the background incidence of myocarditis in Singapore. RESULTS: As of end July 2021, a total of 34 cases were reported (9 pericarditis only, 14 myocarditis only, and 11 concomitant pericarditis and myocarditis) with 7,183,889 doses of COVID-19 mRNA vaccine administered. Of the 9 cases of pericarditis only, all were male except one. The highest incidence of pericarditis was in males aged 12-19 years with an incidence of 1.11 cases per 100,000 doses. Of the 25 cases of myocarditis, 80% (20 cases) were male and the median age was 23 years (range 12-55 years) with 16 cases after the second dose. A higher-than-expected number of cases were seen in males aged 12-19 and 20-29 years, with incidence rates of 3.72 and 0.98 case per 100,000 doses, respectively. CONCLUSION: Data from the national registry in Singapore indicate an increased incidence of pericarditis and myocarditis in younger men after COVID-19 mRNA vaccination.

First transcatheter aortic valve implantation for severe pure aortic regurgitation in Asia.

Transcatheter aortic valve implantation (TAVI) has become the standard of care for inoperable patients with symptomatic severe aortic stenosis (AS), and an alternative to open aortic valve replacement for patients at high surgical risk. TAVI has also been performed in several groups of patients with off-label indications such as severe bicuspid AS, and as a valve-in-valve therapy for a degenerated surgical bioprosthesis. Although TAVI with CoreValve® prosthesis is technically challenging, and global experience in the procedure is limited, the procedure could be a treatment option for well-selected patients with severe pure aortic regurgitation (AR). Herein, we report Asia's first case of TAVI for severe pure AR in a patient who was at extreme surgical risk, with good clinical outcome at six months.

Addressing the burden of type 2 diabetes and cardiovascular disease through the management of postprandial hyperglycaemia: an Asian-Pacific perspective and expert recommendations.

The world is facing an epidemic of cardiovascular disease (CVD) and type 2 diabetes, with populations in low- to middle-income countries, including many in the Asia Pacific (AP) region, being disproportionately affected. Emerging data identify postprandial hyperglycaemia (PPHG) as an important predictor of CVD, and several professional bodies, including the International Diabetes Federation, have issued guidelines on the management of PPHG in type 2 diabetes. Guidance on how international recommendations could be implemented in Asian populations is currently lacking. Therefore, a panel of experts from the AP region convened to consider the current status of PPHG and CVD in the region, and to develop recommendations for clinical practice. The group concluded that improved awareness of the impact of PPHG on CVD risk, among clinicians and the general public, and more widespread use of routine screening for PPHG, using oral glucose tolerance testing in those without recognised diabetes, are required. Additionally, frequent meal-based testing and effective PPHG management are essential to the management of IGT and type 2 diabetes.

Effectiveness and safety of the genous endothelial progenitor cell-capture stent in acute ST-elevation myocardial infarction.

The endothelial progenitor cell (EPC)-capture stent promotes endothelialization and preliminary studies have suggested its safety and feasibility in ST-elevation myocardial infarction (STEMI). Detailed late clinical follow-up and angiographic analyses are, however, limited. We sought to determine late angiographic and clinical outcomes of the Genous EPC-capture stent in primary angioplasty. EPC-capture stents were implanted during primary angioplasty in 489 consecutive patients presenting with STEMI from 2004 through 2008. The first 100 consenting patients undergoing successful stent implantation scheduled to undergo relook coronary angiography at 6 to 12 months were enrolled. Ninety-five patients with 96 lesions were analyzed independently. Mean duration of follow-up coronary angiography was 245 days. In-stent late luminal loss measured 0.87 ± 0.67 mm. Binary restenosis (defined as >50% diameter stenosis) was 28%, with diffuse in-stent restenosis (Mehran class II) as the predominant pattern. Of 27 patients with binary restenosis, 14 (52%) were symptomatic, with 10 patients undergoing target lesion revascularization. Asymptomatic patients had significantly larger reference vessel and in-stent minimal luminal diameters (2.77 ± 0.39 vs 2.54 ± 0.44 mm, p = 0.040; 2.74 ± 0.34 vs 2.31 ± 0.72 mm, p = 0.004, respectively). Follow-up late loss and diameter stenoses were also in favor of the asymptomatic group. Major adverse cardiac event rate was 16% at a mean follow-up of 34 months. There were no cases of Academic Research Consortium-defined stent thrombosis. In conclusion, implantation of the EPC-capture stent during primary angioplasty is associated with a favorable late clinical outcome but with higher than anticipated angiographic late loss.

Angiographic no-reflow and six-month mortality in elderly (>/= 75 years old) Asian patients undergoing primary percutaneous coronary intervention: A single center experience from 1998 to 2007.

BACKGROUND: We sought to report the incidence of angiographic no-reflow and clinical outcomes of elderly patients who have undergone primary percutaneous coronary intervention at a tertiary institution in Singapore over a period of 10 years. METHODS: A total of 141 patients (60% male) aged 75 or above underwent primary PCI between 1998 and 2007. Their average age was 80+/-5 years. Cardiogenic shock complicating STEMI on presentation accounted for 15% of the patients. RESULTS: At baseline, 103 (73%) patients have impaired TIMI flow grade (TIMI 0-2), and 38 (27%) have normal flow (TIMI 3). At the end of the procedure, 44 (31.2%) patients had no-reflow phenomenon (TIMI 0-2), whereas 97 (68.8%) achieved normal antegrade flow. Post-procedure corrected TIMI frame count was analyzable in 66% (n=93) of the patients. Post-procedure corrected TIMI frame count was>28 in 37.6% (n=35) of patients. In-hospital, 30-day and six-month mortalities were 20.6, 25.5% and 27.7%, respectively. Multivariable analysis showed that age 80 or above, low systolic blood pressure and final TIMI 0-2 flow independently predicted six-month mortality. CONCLUSIONS: We found that one-third of the treated patients developed no-reflow phenomenon. Six-month mortality was 27.7%, most were cardiac deaths that occurred during index hospitalization.

Relation between combining evidence-based medications on mortality following myocardial infarction in patients with and without renal impairment.

BACKGROUND: Antiplatelet agents, beta-blockers, statins and ACE inhibitors have been shown to reduce mortality in patients following myocardial infarction (MI). However, it is uncertain if the combination of these agents has a similar impact on mortality following MI in patients with renal dysfunction. METHODS: We studied 5529 consecutive patients with confirmed MI between January 2000 and December 2003. Data on baseline demographics, co-morbidities and in-hospital management were collected prospectively. Glomerular filtration rate (GFR) was estimated using the 4-component Modification of Diet in Renal Disease equation. Based on discharge use of evidence-based medications, the patients were divided into those using 0, 1, 2, 3 or 4 medications. The impact of medication use on 1-year mortality was then assessed for patients with GFR > or =60 ml/min/1.73 m2 (group I) and GFR < 60 ml/min/1.73 m2 (group 2). RESULTS: Mean age was 63 +/- 13 years with 71% men.The prevalence of reduced GFR was 35% and the adjusted odds ratio for I-year mortality of patients in group 2 compared to those in group I was 1.86 (95% CI 1.54-2.25, P < 0.001). Compared with patients with no medication, the adjusted odds ratio for 1-year mortality was lower in patients with 1, 2, 3 and 4 medications in both groups. There was no significant interaction between the number of medications used and GFR. CONCLUSION: Increased use of combined evidence-based medications was independently associated with a lower 1-year post MI mortality. Such therapies offer similar survival benefit in patients with and without renal dysfunction.

Framingham risk score inadequately predicts cardiac risk in young patients presenting with a first myocardial infarction.

INTRODUCTION: The Framingham Risk Score (FRS) is a well-validated epidemiologic tool used to assess the risk for a fi rst cardiac event. Because young patients presenting with a fi rst myocardial infarction (MI) tend to have less significant risk profiles compared with older patients, we hypothesized that FRS may underestimate cardiac risk in these patients. MATERIALS AND METHODS: We studied 1267 patients between January 2002 and November 2007 presenting with a fi rst MI. Patients with pre-existing diabetes mellitus and vascular disease were excluded. FRS was calculated for each patient. Patients were divided based on their age: group A (<40 years), group B (40 to 64 years) and group C (> or =65 years). RESULTS: The mean age was 54.7 +/- 11 years, 88.4% of the patients were males. Younger patients were more likely to be assigned with lower scores. Based on FRS, 63.0%, 29.3% and 14.2% of group A, B and C patients were classified as low risk (10-year risk for cardiac events<10%) respectively, P <0.001. The sensitivity of FRS in identifying at least intermediate risk subjects (10-year risk for cardiac events >10%) was 37.0% in group A vs 85.8% in group C (P <0.001). The incidence of newly diagnosed diabetes mellitus was higher in younger patients (12.0% vs 13.2% vs 7.1 % in groups A, B and C respectively, P = 0.027). CONCLUSIONS: FRS inadequately predicts cardiac risk in young patients presenting with a fi rst MI. This could be because a significant proportion of these young patients have undiagnosed diabetes mellitus, a coronary artery disease risk equivalent.

Endothelial progenitor cell capture stent implantation in patients with ST-segment elevation acute myocardial infarction: one year follow-up.

AIMS: The Genous endothelial progenitor cell (EPC) capture stent is a bioengineered R stent coated with immobilised antibodies on its stent struts to allow for the capture of circulating EPCs to promote rapid endothelisation. We assessed the impact of this stent in the primary percutaneous coronary intervention (PCI) of patients with acute ST-elevation myocardial infarction (STEMI) and examined its long term clinical outcomes. METHODS AND RESULTS: All patients with acute STEMI without cardiogenic shock who underwent primary PCI between January 2005 and April 2007 and received the stent were enrolled in the study. The study endpoints were major adverse cardiac events (MACE) defined as death, MI and target vessel revascularisation (TVR) at 30 days, six months and one year. A total of 321 enrolled patients received 357 EPC capture stents during the study period. The cohort comprises 81.0% males with mean age of 54.6+/-11.6 years. The mean stent length used was 20.98+/-5.50 mm and mean stent size was 2.99+/-0.32 mm. Ninety-four percent of patients achieved Thrombolysis in Myocardial Infarction (TIMI) 3 flow post-procedurally. The cumulative MACE rate was 8.1% at 30 days, 10.0% at six months and 12.2% at one year. There was one patient who developed acute stent thrombosis and another two with subacute stent thromboses. No late thrombosis or late cardiac mortality was observed in our cohort. The need for TVR was 4.4% at one year. CONCLUSIONS: The use of EPC capture stents in patients who underwent primary PCI for STEMI is safe and showed good clinical outcomes, with low rates of TVR and no late stent thrombosis.

Clinical predictors of stent thrombosis in the "real world" drug-eluting stent era.

BACKGROUND: Drug-eluting stents (DESs) are effective in reducing restenosis and the need for repeat revascularization procedures in patients who undergo percutaneous coronary intervention (PCI). There is however an increased concern with the safety of DES with regard to stent thrombosis (ST). We examined the incidence of ST among patients who received DES and determined the clinical predictors. METHODS: All patients who underwent PCI in our centre were prospectively enrolled in a cardiovascular database. All cases of ST, as defined by 2006 Academic Research Consortium (ARC) hierarchical classification as definite and probable, from August 2002 to August 2006 were reviewed and analyzed. The clinical, angiographic and procedural characteristics of patients who developed ST were compared with those who did not. RESULTS: The study population comprised 1580 patients who received DES implantation. The cumulative incidence of ST was 1.5%: acute ST 0.2%, subacute ST 0.9%, late ST 0.2% and very late ST 0.2%. Mortality and myocardial infarction occurred in 16% and 84% of patients, respectively, as a consequence of ST. Multivariate analysis showed that patients presenting with cardiogenic shock, acute coronary syndrome, presence of multivessel disease, impaired baseline TIMI flow and higher number of stents implanted per lesion were predictive of ST. CONCLUSION: The incidence of DES ST in our 'real world' registry was low. There were clinical and angiographic characteristics identified as independent predictors of ST.

Long-term safety and efficacy are observed after implantation of Zotarolimus-Eluting stent in real-world clinical practice.

AIMS: Zotarolimus-eluting stents (ZESs) have been shown to be safe and effective in randomised trials. We sought to report the clinical outcomes after implantation of ZES in real-world clinical practice. METHODS AND RESULTS: ZES have been approved for clinical use in Singapore since April 2005. Until December 31, 2007, a total of 219 patients had undergone implantation of ZES. After excluding 11 foreign patients with whom contact was lost, 208 patients (246 lesions, 305 stents) formed the study cohort. A high-proportion of diabetic patients (n=90, 43.3%) was included. Recommended dual antiplatelet therapy was at least 3 months (n=147) for patients treated before or 12 months (n=61) after January 2007. As of January 2008, the median follow-up duration was 19 months (range: 1 to 33 months). There were 10 (4.8%) deaths, including 7 (3.4%) cardiac deaths. Myocardial infarction occurred in 11 (5.3%) patients. The numbers of patients requiring target vessel revascularisation and target lesion revascularisation were 10 (4.8%) and 5 (2.4%) respectively. Using the ARC definition, there were two cases of definite stent thrombosis on days 7 and 17, and one case of probable stent thrombosis on day 15. CONCLUSIONS: In this real-world clinical experience, ZES was associated with a low incidence of adverse cardiac events at a medium follow-up of one and half years.

An intravascular ultrasound study of Cypher, Taxus, and endeavor stents on relation between neointimal proliferation and residual plaque burden.

BACKGROUND: Studies on balloon angioplasty, atherectomy, and bare metal stent have shown a direct relation between residual plaque burden and restenosis. We investigated the relation between residual plaque burden and neointimal proliferation after drug-eluting stent (DES) implantation. METHODS: Over a period of 12 months, 65 patients (Cypher, n = 25; Taxus, n = 28; Endeavor, n = 12) from two centers underwent intravascular ultrasound (IVUS) examination at 8.2 (interquartile range 6.8-9.5) months after coronary stent implantation in native de novo coronary arteries. IVUS images were acquired with motorized pullback at 0.5 mm/s, and cross-sectional measurements were performed within the stents at 1-mm intervals. The following measurements were obtained: (1) lumen area (LA), (2) stent area (SA), (3) external elastic membrane area (EEMA), (4) percent neointimal hyperplasia area (SA-LA/SA) x 100, and (5) percent residual plaque area (EEMA-SA)/EEMA x 100. RESULTS: The analysis of 1,173 cross sections (Cypher, n = 436; Taxus, n = 532, Endeavor, n = 205) using mixed model to account for intrasubject correlation showed an absence of relation between percent residual plaque area and percent neointimal hyperplasia area (P = 0.189). Mean residual plaque burden outside the stent for Cypher, Taxus, and Endeavor groups was similar (45.7%, 44.8%, and 42.4%, respectively). Mean percent neointimal hyperplasia area for the Cypher, Taxus, and Endeavor groups was 12.0%, 15.0%, and 16.2%, respectively (P = 0.163). CONCLUSION: In patients after first-generation DES implantation and without significant in-stent restenosis, late in-stent neointimal proliferation is not related to the amount of residual plaque burden after stent implantation. This suggests against routine plaque removal before DES implantation to reduce neointimal proliferation.

Clinical experience of StarClose vascular closure device in patients with first and recurrent femoral punctures.

OBJECTIVE: We present our clinical experience of StarClose in patients undergoing coronary interventions, including its use in patients after repeated puncture of the same femoral access site. BACKGROUND: The StarClose is a novel vascular closure device that deploys a small, flexible, circumferential nitinol clip onto the femoral artery surface. METHODS: In this study, 103 consecutive patients (24% with repeated punctures) who underwent percutaneous coronary intervention and received a StarClose were followed up prospectively. The patients were assessed for vascular complications prior to hospital discharge. Device success, based on time-to-hemostasis, was divided into (1) immediate success: hemostasis achieved immediately after StarClose deployment without the need for adjunctive manual compression, (2) partial success: occurrence of minor oozing after StarClose deployment and hemostasis achieved after <3 minutes of manual compression, and (3) device failure: need for adjunctive manual compression for >3 minutes. RESULTS: Immediate success, partial success, and device failure rates were 74% (n = 68), 16% (n = 15), and 10% (n = 9), respectively. There were no major complications attributable to the StarClose device. There were 10 (9.7%) cases of minor complications; all were recurrent wound bleeding requiring manual compression in the wards. Among these 10 cases of recurrent bleeding, 5 (50%) had initial device success (immediate success, n = 2, partial success, n = 3) in the catheterization laboratory. The risk for recurrent bleeding was 2.9% after immediate device success and 20.0% after partial device success. CONCLUSION: Our study found no major complications but a 10% failure rate and a 9.7% rate of minor complications. Close surveillance is important as there is a risk for recurrent bleeding, especially in patients with partial device success as defined in this report.